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NCT Number: NCT01644747

tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients

The aim is to investigate the effect of transcranial Direct Current Stimulation (tDCS) applied at the anodal left CDLPF of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment in resistant depression stabilized for 4 weeks (antidepressant as SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for unipolar patients and lithium for bipolar patients). The delay of 4 weeks is a minimum to observe a non-response. Moreover, in term of ethical point of view, it's difficult to wait 6 to 8 weeks to observe the non-response to treatment.

This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients (48 unipolar plus 12 bipolar patients per group. Patients will be selected in the psychiatric department of the University Hospital of different centers and the two groups are matched for age (+/- 5 years), gender and depression diagnosis (unipolar vs bipolar).

After giving informed consent, patients will be evaluated by a psychiatrist using the Hamilton Depression Rating Scale (HDRS), Montgomery Asberg Depression Rating Scale (MADRS), the STAI and Beck Depression Inventory (BDI) and for bipolar patient only, by the Young Mania Rating Scale (YMRS). The complete assessment takes 50 minutes. A neuropsychologist assessment will be also realized during 20 minutes using the Crossing of Test (COT), the Trail Making Test (TMT), the Isaacs Set Test (IST) and the Cardebat fluency Task.

After locating the left DLPFC, treatment with active tDCS with a current of 2 mA or sham will be directed by 30-minute session. A psychometric assessment will be conducted again at the end of treatment week and 4, 12 and finally 24 weeks after stopping treatment. The neuropsychologist assessment will be conducted again 4 weeks after the end of treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment.

These people will be recruited on a voluntary basis, after notification and consent in the 6 research centers. This study was conducted over a period of 36 months.

This study was supporting by a grant from the French Hospital Program of Clinical Reseach (PHRC N/2011-60-2011-A01074-37)

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Key information

Conditions

Resistant Depression Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Mental Disorders Mood Disorders Moods Disorders Unipolar Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808), Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subject whose MDD are single or recurrent without psychotic features according to DSM-IV-TR
  • subject with a diagnosis of resistant major depression (≥1 failed antidepressant treatments for the current depressive episode)
  • HDRS-21 score ≥ 21
  • drug treatment by SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients for at least 4 weeks
  • right-handed patients
  • without severe progressive somatic pathology (especially tumor diseases, degenerative diseases)
  • without severe cognitive impairment making psychometric evaluation impossible
  • excepted antidepressant or Lithium treatment, psychotropic following are tolerated during the course of the study : hydroxyzin; cyamemazin (up to 100 mg/day) ; hypnotics (imidazopyridin).

Exclusion criteria

  • subject treated with antipsychotics or mood stabilizers or anticonvulsants or by ECT or rTMS for the current depressive episode
  • subject resistant to SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients
  • subject with mixed features
  • pregnancy and/or lactation
  • presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)

Treatment and study plan

transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)

Device

After locating the left DLPFC, ttt with active anodal tDCS with a current of 2 mA or sham over the left DLPFC will be directed by 30-minute session. Treatment will occur 2 sessions per day during 5 days per week. Subjects will be monitored during tDCS for any side effects or adverse events.

Other names: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Ilmenau, Germany)

Primary outcomes

  1. change from baseline in HDRS-21 scale

    Time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk

    The changes in HDRS-21 will constitute the major research outcome measure used to assess response to tDCS. Response to treatment is defined as a ≥ 50% reduction in the scores of the HDRS. Remission is defined as a HDRS score ≤ 8.

Secondary outcomes

  1. Change from baseline in MADRS, BDI, HAMA, STAI, YMRS

    Time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk

    Montgomery and Asberg Depression Rating Scale (MADRS) Beck Depression Inventory-13 (BDI) Subscores for anxiety depression scale from HDRS-21 State-Trait Anxiety Inventory (STAI) Young Mania Rating Scale (YMRS) : only for bipolar patient

  2. Change from baseline in COT, TMT, IST and Cardebat fluency task

    Time frame: baseline, 4wk

    Crossing of test (COT) Trail Making test (TMT) Isaacs Set Test (IST) Cardebat fluency task

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • CH Le Vinatier - Service de Psychiatrie (Dr Emmanuel POULET)
  • Clinical Investigation Centre for Innovative Technology Network
  • EPS Ville-Evrard - Unité de Recherche Clinique (Dr Dominique JANUEL)
  • Hôpital Civil de Strasbourg - Service de Psychiatrie (Pr G.Bertschy)
  • Rennes University Hospital
  • University Hospital, Grenoble

Registry information

Official study title

tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients: a Randomized, Double-blind, Placebo Controlled Study

Acronym: STICODEP

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2012
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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